Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia (PLEASURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01160679
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : August 18, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date July 7, 2010
First Posted Date July 12, 2010
Last Update Posted Date August 18, 2011
Study Start Date August 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2010)
  • The change of total score of SHAPS [ Time Frame: At baseline ]
  • The change of total score of SHAPS [ Time Frame: At 12 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 9, 2010)
  • Changes of Clinical Global Impression (CGI)-Severity score [ Time Frame: At baseline ]
  • Changes of Clinical Global Impression (CGI)-Severity score [ Time Frame: At 12 weeks ]
  • Proportion of patients having a score of 1 or 2 in CGI-I score [ Time Frame: At 12 weeks ]
  • Proportion of significantly improved patients in SHAPS total score (more than 30%) [ Time Frame: At baseline ]
  • The mean change MADRS total score [ Time Frame: At baseline ]
  • The mean change MADRS total score [ Time Frame: At 12 weeks ]
  • Proportion of significantly improved patients in SHAPS total score (more than 30%) [ Time Frame: At 12 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
Official Title Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
Brief Summary This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25 hospitals in naturalistic treatment setting. There will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Department of psychiatry of 25 hospitals
Condition Schizophrenia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 17, 2011)
231
Original Estimated Enrollment
 (submitted: July 9, 2010)
500
Actual Study Completion Date August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Documented clinical diagnosis of schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders,(DSM-IV-TR) criteria
  • Patients who already take one atypical at inclusion it is started at least 1 week and up to 4 weeks before the inclusion

Exclusion Criteria:

  • Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I
  • Patients with antipsychotic combinations (more than two agents)
  • Patients who are already on any mood stabilizers and antidepressant
  • Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment
  • Patients who have been treated with antipsychotics in depot formulations for the last two months
  • Previous enrollment or randomisation of treatment in the present NIS
  • Patients who had participated in other clinical trials within 4 weeks prior to enrollment period
  • Pregnant women or women who are breast-feeding
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01160679
Other Study ID Numbers NIS-NKR-SER-2010/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marketing Company Medical Director, AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Study Chair: Sang-Woo Han, MD, PhD Department of Psychiatry
PRS Account AstraZeneca
Verification Date August 2011